A single-subject research design evaluating a co-created yoga program for adults with gynecologic cancer: feasibility study protocol

Abstract

Background Worldwide, > 1.3 million adults are diagnosed with a gynecologic cancer each year, affecting their wellbeing and quality of life. This manuscript describes the protocol for a study that sought to assess the feasibility, acceptability, and fidelity of a community-based co-created yoga program and proposed evaluative methods, and estimate program effects on self-reported outcomes. Methods Using a multiple baseline single-subject research design with a follow-up phase (ABA), quantitative and qualitative data were collected from program participants and the instructor. Participants were randomly assigned to varying baseline lengths and completed weekly surveys for 3–5 weeks pre-program. Then, participants engaged in a bi-modal 12-week hatha yoga program consisting of 2 60-min group classes a week, with optional supplemental features (January–April, 2023). Participants completed surveys after classes 1, 12, and 24. All yoga classes were audio- and video-recorded. Post-program, participants completed surveys 1, 4, and 8 weeks after the last class and took part in a semi-structured interview 1 week after to discuss program acceptability, suitability, relevance, and potential benefits. Feasibility outcomes (i.e., recruitment, retention, and program adherence rates, engagement with optional program features) were tracked by the instructor assistant and study team during the study. The yoga instructor was interviewed about their experience delivering the program 2 weeks after the last class. Planned analysis Feasibility outcomes will be analyzed using descriptive statistics. Interview transcripts will be coded using reflexive thematic analysis. Class recordings will be coded using duration and frequency coding. Survey responses for self-reported outcomes will be analyzed visually and using multilevel modeling. Expected outcomes Data will help determine refinements, if any, required to the program and instructor guidebook, implementation approach, and proposed evaluation methods before scale-up projects and definitive trials are started. Trial registration ClinicalTrials.gov NCT05610982. November 3, 2022.